Background & Aims

The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens.

Methods

Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L + 2 L) (High-SD) or low volume (1 L + 1 L) + bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates.

Results

Over 29 months, 2314 subjects were randomized to High-SD (N = 1157) or Low-SD (N = 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P = .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P < .01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P < .01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P = .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P < .01), a finding not seen in the Low-SD group.

Conclusions

Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).

中文翻译：

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肠道清洁国家倡议：高容量分次剂量与低容量分次剂量聚乙二醇制剂：随机对照试验

背景与目标

本研究的目的是比较高容量聚乙二醇 (PEG) 与低容量 PEG 与比沙可啶分次给药方案。

方法

加拿大 10 家三级医院的成人门诊患者被随机分组​​，通过早上或下午的结肠镜检查分层，接受高容量分次剂量 PEG (2 L + 2 L) (High-SD) 或低容量 (1 L + 1 L) + 比沙可啶 ( 15 mg) PEG (Low-SD)，第二次随机分配至流质或低残留饮食。使用非劣效性假设检验的主要终点是充分的肠道清洁（波士顿肠道准备量表总分≥6，3 个结肠节段的每个分项≥2）。次要目标是愿意重复准备、退出时间、盲肠插管和息肉检出率。

结果

在 29 个月内，2314 名受试者被随机分配到高 SD（N = 1157）或低 SD（N = 1157）（平均年龄，56.2 ± 13.4 岁；52.1% 女性）。结肠镜检查适应症为 38.2% 的诊断、36.8% 的筛查和 25.0% 的监测，患者特征没有组间不平衡。与高 SD 相比，低 SD 满足非劣效性标准以获得足够的肠道清洁度，结果略差（90.1% vs 88.1%；P  = .02；差异，2.0%；95% CI [0.0%；4.5%]）。高 SD 与较低的重复意愿相关（66.9% vs 91.9%；P < .01），耐受性较差（7.3 ± 2.3 vs 8.1 ± 1.9；P < .01），导致更多症状。除了 High-SD 后盲肠插管率更高（97.4% vs 95.6%；P  = .02)。在高 SD 组中，清流质饮食后肠道准备充分（93.6% vs 87.9%；P < .01），这一发现在低 SD 组中未见。

结论

在提供充分的肠道准备方面，低 SD 不劣于高 SD。低 SD 导致更少的症状，更愿意重复和耐受性。饮食的总体影响是适度的。该研究得到了所有地点的研究伦理委员会的批准，并在 ClinicalTrials.gov (NCT02547571) 上注册。